Biopharmconsortium Blog

Expert commentary from Haberman Associates biotechnology and pharmaceutical consulting.

Posts filed under: Biomarkers

Can adoptive cellular immunotherapy successfully treat metastatic gastrointestinal cancers?

Tweet  On September 6, 2014, we published an article on this blog announcing the publication of our book-length report, Cancer Immunotherapy: Immune Checkpoint Inhibitors, Cancer Vaccines, and Adoptive T-cell Therapies, by Cambridge Healthtech Institute (CHI). In that article, we cited the example of the case of a woman with metastatic cholangiocarcinoma (bile-duct cancer), which typically…

Immune checkpoint inhibitors work by reactivating tumor-infiltrating T cells (TILs)

TweetThe 27 November issue of Nature contains a wealth of new studies on how immune checkpoint inhibitors target various types of cancer, and how researchers and physicians might be able to identify the patients who are most likely to benefit from treatment with these agents. These studies are described in five papers published in that…

Chemokine receptors and the HIV-1 entry inhibitor maraviroc

TweetIn April 2012, Informa’s Scrip Insights published our book-length report, “Advances in the Discovery of Protein-Protein Interaction Modulators.” We also published a brief introduction to this report, highlighting the strategic importance of protein-protein interaction (PPI) modulators for the pharmaceutical industry, on the Biopharmconsortium Blog. The report included a discussion on discovery and development of inhibitors…

Cancer immunotherapy: the star of the ASCO Annual Meeting two years in a row!

TweetOn June 28, 2012 we published an article on this blog entitled “Cancer Immunotherapy: The Star Of The 2012 ASCO Annual Meeting”. Now comes the American Society of Clinical Oncology (ASCO) 2013 Annual Meeting, which took place from May 30 to June 3, 2013. As in 2012, cancer immunotherapy was the star of the meeting….

FDA proposes accelerated approval of early-stage Alzheimer’s drugs based on cognitive improvement alone

TweetIn our February 28, 2013 article on the Biopharmconsortium Blog, we discussed the FDA’s February 7, 2013 Draft Guidance for Industry entitled “Alzheimer’s Disease: Developing Drugs for the Treatment of Early Stage Disease”. This document had been distributed for comment purposes only, and the FDA has been seeking public comment on the draft guidance for…

FDA publishes Draft Guidance on developing drugs for early stages of Alzheimer’s disease

Tweet  Once again, approaches to improving clinical trials for candidate disease-modifying drugs for Alzheimer’s disease (AD) are in the news. On February 7, 2013, the FDA issued a Draft Guidance for Industry entitled “Alzheimer’s Disease: Developing Drugs for the Treatment of Early Stage Disease”. This document has been distributed for comment purposes only, and the…

Here we go again–Lilly’s Alzheimer’s drug solanezumab fails to show efficacy in Phase 3, but company is “encouraged” by secondary analysis

Tweet  As we mentioned in our August 19, 2012 article on Alzheimer’s disease (AD), the results of Phase 3 trials of Lilly’s amyloid-targeting monoclonal antibody (MAb) drug solanezumab, had been expected soon. On August 24 2012, Lilly announced the top-line results of the two Phase 3, double-blind, placebo-controlled EXPEDITION trials of solanezumab in patients with…

New genetics study supports the amyloid hypothesis of Alzheimer’s disease–but the drugs still don’t work!

Tweet  An exciting new study on Alzheimer’s disease (AD) was published in the 2 August issue of Nature. The study was carried out by researchers at deCode Genetics (Reykjavik Iceland) and their collaborators at Genentech and several academic institutions. A News and Views article by leading AD researcher Bart De Strooper and genomics researcher Thierry…

Cancer immunotherapy: The star of the 2012 ASCO Annual Meeting

Tweet  The American Society of Clinical Oncology (ASCO) held its 2012 Annual Meeting on June 1-5, 2012. Arguably the highlight of the meeting was the June 2, 2012 presentation by Bristol-Myers Squibb (BMS) on its Phase 1 immunotherapeutic, anti-PD-1 (BMS-936558). The results of this study were also published ahead of print on June 2, in…

Co-clinical mouse/human trials for cancer continue to advance

Tweet  Two previous articles on this blog have included discussions of the “co-clinical mouse/human trial” strategy for improving mouse models of human cancer, and simultaneously improving human clinical trials of drugs for these cancers. Now comes an article on the use of a co-clinical trial strategy in personalized treatment of non-small cell lung cancer (NSCLC)…